Audra Fox, MD 40th Annual CME Conference for Physician Assistants 24 October 2013

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Audra Fox, MD

40th
Annual CME Conference for Physician
Assistants

24 October 2013


Discuss insomnia and traditional treatments


Define CAM and commonly misunderstood terms


Discuss briefly the 5 domains as defined by the NIH


Use the 5 domains to discuss CAM therapies for
insomnia




I have no financial disclosures or conflicts of interests.


repeated difficulty with the


initiation


duration


maintenance


or quality of sleep


occurs despite adequate time and opportunity for sleep


results in some form of daytime impairment.


Acute or adjustment insomnia


lasts up to 3
-
6 months


acute situational stress such as a new job or an upcoming
deadline or examination


typically resolves when the stressor is no longer present
or the individual adapts to the stressor


Transient insomnia


Last for about 1 week


often recurs when new or similar stresses arise in the patient’s life.


Chronic or persistent insomnia


lasts longer than 6 months


can be associated with a wide variety of medical and psychiatric
conditions


3 subtypes


Secondary insomnia


medical and psychiatric problems


menopause, GERD, advanced age, chronic pain


pseudoephedrine, beta
-
blockers, inhalers


chronic use of drugs and alcohol, including caffeine


Primary sleep disorders


circadian rhythm disorders


central sleep apnea
-
insomnia syndrome


inadequate sleep syndromes


periodic limb movement or restless leg syndrome


Idiopathic insomnia
-

sleeplessness without a known cause


Avoid aspartame (Nutritional Medicine)


adversely impacts performance


increasing risk for accidents


increased risk


cardiovascular disease


cancers


metabolic disorders


autoimmune disorders


infection


obesity


chronic inflammatory processes


Wake up rested and enough energy for the day.

Age and condition

Average amount of sleep per day

Newborn

up to 18 hours

1

12 months

14

18 hours

1

3 years

12

15 hours

3

5 years

11

13 hours

5

12 years

9

11 hours

Adolescents

9

10
hours

Adults, including elderly

7

8 hours

Pregnant women

8(+) hours


Circadian cycles
-

“body clock”


Daily variations of physiological functions


regulated by the suprachiasmatic nucleus (SCN) of the
hypothalamus


Secretion of melatonin


Drop in core body temperature


Forced disruption of circadian cycles in animals
reduces life span.


Shift work is associated with increased risk for
physical and mental illness, especially GI
disorders and depression.


It is interesting to note that there is a prominent
cyclic signature to many mental disorders
including manic
-
depression, bipolar processes,
MDD recurrent, etc. Is it possible that these are
somehow related to circadian dysrhythmias?





T
RADITIONAL

W
ESTERN



M
EDICINE


CAM / Integrative


Medicine


Am Fam Physician.

2007

Aug

15;76(4):517
-
526.


Treatment Options for Insomnia


KALYANAKRISHNAN RAMAKRISHNAN, MD, and DEWEY C.
SCHEID, MD, MPH, University of Oklahoma Health Sciences
Center, Oklahoma City, Oklahoma


http://www.aafp.org/afp/2007/0815/p517.html





Traditional Western


Medicine


CAM / I
NTEGRATIVE



M
EDICINE


Conventional / Western / Allopathic medicine


practiced by holders of M.D. and D.O. degrees and by allied
health professionals, such as physical therapists,
psychologists, and registered nurses


CAM


complimentary and alternative


“Healing philosophies, approaches, therapies that mainstream
Western medicine does not commonly use, accept, study,
understand or make available”


Complimentary
-

the use of CAM together with
conventional medicine


Alternative
-

use of CAM in place of conventional
medicine


Integrative
-

a practice that combines both
conventional and CAM treatments for which there is
evidence of safety and effectiveness


40
-
60% Americans use
CAM each year



Overwhelming majority
seek care from their
physician BEFORE they see
an alternative provider



1999, NIH created NCCAM


Nat’l Center for
Complimentary and
Alternative Mecidine.


Eisenberg DM et al
Ann Intern Med

2001;135:344


1.
Biologically based

2.
Manipulative & Body
-
based

3.
Energy Medicine

4.
Mind
-
Body Medicine

5.
Whole Medical System


Dietary supplements


Botanicals / Herbal products


Probiotics


Precursors to melatonin


have not been proven effective in treating insomnia


there are concerns that they may be

linked to eosinophilia
-
myalgia

syndrome (EMS)


a complex and debilitating systemic

condition with multiple symptoms

including severe muscle pain.


5
-
HTP readily crosses the blood
-
brain

Barrier.
(Bruni O 2004; Sarzi Puttini 1992)


50
-
100 mg, 30
-
60 min prior to bedtime



Hormone secreted by the pineal gland


Plays a role in sleep
-
wake cycle


The dramatic decline in the variation of our experience of the
natural environment has affected melatonin cycles.


extensive daytime sheltering from natural light and nighttime use of artificial light have reduced
the range of human biological functions by altering natural MT cycles contributing to systemic
health dysfunctions (
Yun
, 2005)


Endogenous MT can also be effectively increased with light
management.


The blue end of the light spectrum which is present in natural and
artificial light suppresses MT.


Blue
-
blockers, lights or lenses that block the short wavelength of
visible light have been shown to facilitate increases in evening MT.
(
Raloff

J, 2006)


Dusk simulation, dimming ambient light for an hour or two prior to
bedtime also appears to help increase endogenous MT production
(
Naiman

R, 2006).



Caffeine, nicotine and alcohol interfere with MT
production.


NSAIDs, beta
-
blockers (propranolol and atenolol)
suppress MT.


Benzodiazepines, diuretics, and calcium channel
blockers can interfere with synthesis of MT

(Burnham, 2001; McEvoy, 2001; Bratman, 2001)


Electromagnetic fields, which occur in the vicinity of
electrical devices such as bed stand clocks and
hairdryers, can suppress MT
(Reiter, 1994)


Physiologic dose is 0.3 mg at night


Pharmacological dose is 2
-
5 mg


May induce hypothermia


May elevate levels during the day causing drowsiness


Doses for cancer range from 20 mg to 80 mg



SL by
-
passes liver metabolism


2 mg sustained release administrated to pts age 55
-
80
was significantly more effective than placebo in
improving sleep

(Wade et al. 2007)



Vitamin B6 and B12
-

promote MLT production



In several animal studies,
methylcobalamin

injections:



improved production of melatonin


(Inoué,1994)


enhanced melatonin
-
induced circadian phase shifts


(Ikeda, 1998; Takahashi, 1993).


Methyl
-
B12 donates a methyl group to S
-
adenosyl

l
methionine

(SAM
-
E), which donates a methyl group in
the production of melatonin. Therefore,
transmethylation

by methyl
-
B12 may
promote
melatonin biosynthesis
.


(
Pfohl
-
Leszkowicz
, 1991;
Sitaram
, 1995).



Clinically, several case studies and small studies describe
success using high dose oral
methylcobalamin

in
adolescents and adults who suffered from sleep
disorders, some intractable to numerous medications


(
Ohta
, 1991;
Okawa
, 1998; Mayer, 1996;
Tomoda
, 1994).


Interestingly, these children did not demonstrate
B12 deficiency; in fact, their B12 levels were normal
or elevated
. This may be related to an undetected
inability to absorb vitamin B12, due to a
methylation

defect or another derangement
preventing transport into
the cell
.



Some discrepancies exist in studies between oral and IM


PO 1500
-
3000 mcg / day


does not seem to be as effective


IM 1000 mcg q 1
-
4 weeks


more effective



involved in the synthesis of the neurotransmitters


serotonin, dopamine, norepinephrine, and gamma
-
aminobutyric acid (GABA) in the brain and nerve cells,


may support mental function (mood) and nerve
conduction.


Any deficiency of pyridoxine can quickly lead to
insomnia and a profound malfunctioning of the central
nervous system.


necessary for hemoglobin synthesis and red blood
cell growth, maintaining healthy immune system
function, and prevention of atherosclerosis.


Increases serotonin


Increase REM sleep


1
-
3 g / day


Can cause elevation in LFTs


Can be used in combination with L
-
Trytophan


Nonessential amino acid


beef, poultry, fish and seafood


Inhibitory neurotransmitter


Used to treat schizophrenia


Waking up in the middle of the night


Reduces core body temperature


Reduces fragmentation of sleep architecture


Promotes longer periods spent in deep slow
-
wave sleep



(Yamadera W, et al 2007)


300
-
500 mg / day


Improve efficiency in patients with insomnia
associated with restless legs syndrome or periodic limb
movements


The German Commission E, ESCOP and WHO all recognize the use of valerian for
restlessness and as a mild sleep
-
promoting agent in nervous or anxiety
-
induced sleep
disturbances.


Preparation & Dose


Infusion
: Pour 5 ounces over 3
-
5 grams (1 tsp) valerian root and steep for 10
-
15
minutes (Wichtl, 1994). Drink before bed or 2
-
3 times per day as needed.


Tincture
: 1
-
3 ml 1
-
3 times day (1:5, 70% alcohol)


Standardization
: Extracts are often standardized to contain 0.3
-
0.8% valerenic
acid.


Clinically tested products

available in the US include:


Sedonium® (Lichtwer Pharma AG, Germany, distributed by Lichtwer Pharma
US, Inc). Ethanolic extract (LI 156). Dose used in clinical trials 600 mg before
bed.


Valerian Night
-
time® (Dr. Willmar Schwabe GmbH & Co., Germany, distributed
by Nature’s Way Health Products, Inc). Hydroethanolic extract of valerian and
lemon balm (Melissa officinalis). Dose used in clinical trials 1
-
4 tablets/d
(valerian 160 mg/lemon balm 80 mg tablet).


Alluna Sleep® (Zeller AG, Switzerland, distributed by GlaxoSmithKline). Extract
of valerian and hops (Humulus lupulus) (Ze 91019). Dose used in clinical trials:
1
-
3 tablets/d (valerian 500 mg/hops 120 mg per tablet).


NIH
-

14 page handout


widely known for their relaxant effects


In a study by Muller, 918 children with hyperkinesis
and dyssomnia were treated with for 4 weeks with
“Euvagel,” a combination of valerian and lemon balm.
Seventy percent of children with hyperkinesis and 80%
of insomnia improved significantly (Muller, 2006).


Withanolides, key constituents in the plant, induced an
anxiolytic effect comparable to that produced by lorazepam
after being administered orally to rats once daily for five
days.


For sleep disturbances, ashwagandha used with lorazepam
mitigated negative side effects of benzodiazepines


Preparation and dose:


Crude herb: 1
-
6 grams per day of the dried root, taken in 2
-
3 divided
doses


Tincture (1:5): 2
-
4 milliliters, taken 3 times daily


Extract: 500 mg 2
-
3 times per day standardized extracts containing
2.5% withanolides




Widely used by practitioners of herbal medicine in Europe
and North America for treatment of


insomnia, mania, anxiety, toothache, and nerve pain.


The German Commission E Monographs list hops as
approved for anxiety and sleep disturbance.


Small studies have looked at the combination of valerian
and hops for insomnia and suggested helpful effects



(
Koetter
, 2007; Morin, 2005;
Fussel
, 2000).


Recommended dose is 300
-
500 mg before bed either in
capsule or tincture.





Spinal manipulation


Massage therapy


“Movement Therapies”


Feldenkrais method


Alexander technique


Pilates


Rolfing Structural Integration


Trager psychophysical integration


Massage has long been known to enhance relaxation
and improve sleep patterns. While massage alone is an
effective method for relaxation, studies suggest that
massage with essential oils (called aromatherapy),
particularly lavender (
Lavandula angustifolia
), may
result in improved sleep quality, more stable mood,
increased mental capacity, and reduced anxiety.


Clinical studies have found participants who received
massage with lavender felt less anxious and more
positive than participants who received massage alone.



No well
-
designed studies have evaluated the effect of
chiropractic care on individuals with insomnia, but
chiropractors report that spinal manipulation may
improve symptoms of the condition in some
individuals. In these cases, spinal manipulation may
have a relaxing effect on the nervous system.



Magnet therapy


Light therapy


Qi gong


Reiki


Healing touch


Ki Iki Jutsu


Acupuncture


In 1982 The National Institute of Health identified winter depression and coined
the term, ‘SAD’ for Seasonal Affective Disorder


The scientists found that 'SAD' was related to an imbalance in the body's natural
circadian rhythms. The Circadian rhythm, or the body’s inner clock
governs the
timing of sleep, hormone production, body temperature, and other
biological functions
.


In 1984 these pioneering scientists discovered that
exposure to bright white light
is very effective at treating seasonal affective disorder.


For many years doctors had relegated light therapy to the periphery of credible
science. It wasn’t until 2001 that researchers from NIH, Thomas Jefferson Medical
University and Apollo Health fully
understood how exposure to specialized
bright light, stimulates the production of brain chemical
s to relieve the
symptoms associated with seasonal depression


Dr. George Brainard’s team at Thomas Jefferson Medical University, identified a

photo receptor in the human eye
, responsible for reacting to light and controlling
the production of melatonin


From World Health Organization
-

Insomnia


Zhang, 1993 (
110
)


60 per group


Group comparison


Auricular acupressure


Medication (diazepam plus chlorohydrate)


After 1 month of treatment, sleep was restored to normal or markedly improved in:

• 59/60 in the test group

• 20/60 in the control group.


Luo et al., 1993 (
109
)


60 per group


Randomized controlled trial


Auricular acupressure


Medication (phenobarbital, methaqualone or meprobamate)


After the course of treatment, sleep improved in:

• 96.7% of the test group

• 35.0% of the control group.


Meditation


Yoga


Deep
-
breathing exercises


Guided Imagery


Hypnotherapy


Progressive Relaxation


Qi gong


Tai Chi


Insomnia


A matched, randomized trial of hypnosis for insomnia found that hypnosis helped
patients
get to sleep more quickly

than placebo or stimulus control ( Stanton,
1989).


Parasomnias


nightmares, sleepwalking, sleep terror disorders


The results for the patient with the nightmare disorder suggested that the effective
element in
decreasing the frequency of nightmares

may have been the
specific
hypnotic suggestion to alter the nightmare content
. The generalized effects of
increased relaxation and improved sleep also contributed to therapeutic efficacy.


Two other patients with sleepwalking and sleep terror disorders were also treated.
In both the cases the effective ingredient seemed to be the generalized effects of
hypnosis. The case reports suggest that the general lowering of tonic levels due to
the
anxiolytic effects of relaxation

employed during hypnosis was responsible for
reducing the incidence of these disorders.


Conclusion: hypnosis is a relatively simple, non
-
invasive, inexpensive, and
potentially effective means of treating nightmare, sleepwalking, and sleep
terror disorders.


(
Kennedy. 2002. A review of hypnosis in the treatment of parasomnias: Nightmare,
sleepwalking, and sleep terror disorders. Australian Journal of Clinical and
Experimental Hypnosis, 30(2), 99
-
155.)


Tai Chi Chih Improves Sleep Quality in Older Adults


Researchers at the University of California, Los Angeles, conducted a randomized
controlled trial, funded in part by NCCAM, to determine whether tai chi chih could
improve sleep quality in healthy, older adults with moderate sleep complaints.


In the study, 112 individuals aged 59 to 86 participated in either tai chi chih training or
health education classes for 25 weeks. Participants rated their sleep quality based on the
Pittsburgh Sleep Quality Index, a self
-
rate questionnaire that assesses sleep quality,
duration, and disturbances.


The results of the study showed that the people who participated in tai chi chih sessions
experienced slightly greater improvements in self
-
reported sleep quality
.


The researchers concluded that tai chi chih can be a useful nonpharmacologic
approach to improving sleep quality in older adults with moderate sleep
complaints, and may help to prevent the onset of insomnia
.



Naturopathy


Homeopathy


TCM
-

Traditional Chinese Medicine


Ayurveda


Sleep Hygiene


Aromatherapy
-

lavender, chamomile


Chamomile tea before bedtime


Nat’l Sleep Foundation


Sheex


temperature control, moisture transport, breathability (50%
better than cotton)


Comfortex blinds or Sound Asleep room darkening
curtains


Light therapy


Coffea

30
-

Use this medicine when you have mental over
-
activity due to good or bad news and you
are just unable to switch off.




Nux

Vomica

30
-

When you are under enormous mental strain or pressure, or you have withdrawn
recently from alcohol or sleeping tablets. Significant irritability in the daytime will be experienced
when you need this medicine.


Lycopodium

30

-

If you need this medicine you will wake regularly at around 4am. Your mind will be
active at bedtime replaying events from the day over and over. You will dream a lot and talk or laugh
in your sleep.


Arsenicum

30

-

Your wakeful time will be between 12 and 2am and you will feel anxious and very
restless. If you dream, they will be dreams of danger.




Cocculus

30

-

Use this medicine when you are overtired and giddy, irritable from being up looking
after someone else such as a sick child.


Rhus

Tox

30

-

When you cannot sleep because there is pain or discomfort and it makes you feel very
irritable and restless so that you want to get up and walk about.


Simillimum



A 2010 randomized, double
-
blind, placebo
-
controlled study found that patients who
took
simillimum

for 1 month saw significant increases in duration and quality of sleep.


the homeopathic remedy that produces the set of symptoms most like that which the disease produces



Directions:
Take your chosen Homeopathic medicine 30 minutes before bed and repeat when you turn
the light off. Repeat if you wake in the night and use as long as you are getting relief. If you do not
have an improvement stop the medicine.



According to the Chinese Clock,
digestion is the strongest in the
morning, between 7 am and 9
am for the Stomach, and 9 am to
11 am for the Spleen/Pancreas.
Twelve hours later (7 pm to 11
pm) digestion is the weakest,
and eating at this time will cause
gas, bloating and indigestion,
making it difficult for one to fall
asleep easily.


Acupuncture


Heart 7 (
Shen

Men
), on the wrist, which helps calm the heart and spirit


At the wrist crease, on the medial side of the flexor
carpi

ulnaris

tendon, between the ulna and the
pisiform

bones.




AnMian
, an extra point translated as
Peaceful Sleep
, which is on the back of the head,
where the head meets the neck



Yin Tang
, another extra point which is between the eyebrows and promotes relaxation



Chinese Herbs


An
Mian

Pian

(Sleep Peaceful Formula) for quieting the spirit



Gui

Pi Tang

(Restore the Spleen Decoction) which strengthens the energy and nourishes
the heart



Bao

He Wan

(Preserves Harmony Pill) which reduces food stagnation and harmonizes
digestion (if insomnia is due to eating late at night or indigestion)






Learn more: http://www.naturalnews.com/027348_medicine_insomnia_Chinese.html#ixzz1nF5V74iD





Pitta person with insomnia
-

garlic

boiled in milk,
strained out; milk given at bedtime


Ashwagandha





The dried root is prepared as a decoction, usually at a daily
dose of 3
-
6 grams.


The dose for tincture (1:5) is generally 5 ml TID.


Ashwaganda is often combined with other adaptogenic
herbs, such as ginseng.


Treat the underlying problem


Multi
-
factorial


Long term NSAID use and Menopause


Sleep apnea and shift work syndrome


Individualized medicine


you might have to try more
than one thing


Valerian and Hops or Lemon Balm


Melatonin and Glycine


Massage and Aromatherapy



Gaby, A.
Nutritional medicine
. Concord, NH: Fritz
Perlberg

Publishing; 2011.


Goldman, E.
A new approach to promoting healthy sleep
. (12 ed., Vol. 4, pp. 8
-
9). Holistic Primary Care; 2011.


Insomnia
. Maryland: University of Maryland Medical Center. Retrieved from
http://www.umm.edu/altmed/articles/insomnia
-
00096.htm
; 2011.


Insomnia
. Wikipedia. Retrieved from
http://en.wikipedia.org/wiki/Insomnia
;
2012.


Monti
, D., &
Beitman
, B.
Integrative psychiatry
. Oxford, New York: Oxford
University Press; 2010.


Rakel
, D.
Integrative medicine
. (2 ed.). Philadelphia, PA: Saunders Elsevier;
2007.


Sleep disorders and cam: What science says
. Maryland: National Institute of
Health. Retrieved from
http://nccam.nih.gov/health/providers/digest/sleepdisorders
-
science.htm
;
2010.


Valerian.

NIH Office of Dietary Supplements. Retrieved from
http://ods.od.nih.gov/factsheets/Valerian?print=1
; 2008.